Condition: Localized Prostate Cancer, Active Surveillance for Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02435472

Sponsor: University of California, San Francisco

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• ARM A and ARM B:
• Histologically-documented localized (stage < T3) prostate adenocarcinoma
• Patient has selected active surveillance as their management strategy for low- or low-intermediate risk prostate cancer as defined below
• >= 10 core prostate biopsy completed prior to randomization with Gleason sum =< 6 with no pattern 4, or Gleason 3+4 in < 34% of all cores
• Diagnostic or most recent prostate specific antigen (PSA) =< 15 ng/ml, or PSA density (PSAD) < 0.15
• Low to moderate fitness level at baseline (to be assessed via interview with the exercise staff and through the CPET)
• Clearance based on medical chart review and normal electrocardiogram (ECG) (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention
• Able to achieve and complete an acceptable cardiopulmonary exercise test defined as follows: achieving peak or plateau in oxygen consumption concurrent with increased power output; a respiratory exchange ratio >= 1.1 or volitional exhaustion-rating of perceived exertion > 19
• English-speaking
• A priori, we will allow men with concurrent benign prostatic hyperplasia (prostate volume > 50 g) to have a PSA between 10-15 ng/ml; and include men with low volume Gleason 3+4 disease, because such men have similar outcomes on active surveillance to those with Gleason =< 3+3; also a priori, we will allow men with < than a 10 core biopsy at the discretion of the urologist if s/he classifies the patient as "low-risk" and a good candidate for active surveillance based on other favorable features (e.g., tumor molecular tests, prostate imaging, etc.) NON-CANCER CONTROL GROUP (EXPLORATORY ARM C):
• Healthy males age 20-35 or >=60 yrs.
• No history of prostate cancer or other cancer.
• Medical clearance based on medical chart review and normal ECG (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention OR medical clearance based on medical chart review and sub-maximal exercise testing for the remote aerobic training intervention.
• English-speaking.
• Low to moderate fitness level at baseline (to be assessed via interview with the exercise staff and through the CPET; similar to Arms A and B); subjects will be frequency-matched to subjects in the prostate cancer exercise intervention group (Arm A) to have a similar distribution of body mass index and facilitate comparisons between these two groups. NON-RANDOMIZED OBSERVATIONAL COMPONENT ELIGIBILITY:
• Histologically-documented localized (stage < T3) prostate adenocarcinoma.
• Undergoing or initiating active surveillance.
• Medical clearance based on medical chart review and normal ECG (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention.
• English-speaking. Exclusion Criteria
• Any prior or concurrent treatment for prostate cancer
• Use of finasteride or dutasteride within 3 weeks or 6 months, respectively, of study entry
• Uncontrolled illness, physical disability, or other contraindication to aerobic exercise training including, but not limited to:
• Acute myocardial Infarction (within 5 days of any planned study procedure)
• Unstable angina
• Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
• Recurrent syncope
• Active endocarditis
• Acute myocarditis or pericarditis
• Symptomatic severe aortic stenosis
• Uncontrolled heart failure
• Acute (within 3 months) pulmonary embolus or pulmonary infarction
• Thrombosis of lower extremities
• Suspected dissecting aneurysm
• Uncontrolled asthma
• Pulmonary edema
• Room air desaturation at rest =< 85%
• Respiratory failure
• Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (ie infection, renal failure, thyrotoxicosis)
• Mental impairment leading to inability to cooperate NON-RANDOMIZED OBSERVATIONAL AND INTERVENTION COMPONENTS (ARM C): The same

Exclusion Criteria:

• Any prior or concurrent treatment for prostate cancer
• Use of finasteride or dutasteride within 3 weeks or 6 months, respectively, of study entry
• Uncontrolled illness, physical disability, or other contraindication to aerobic exercise training including, but not limited to:
• Acute myocardial Infarction (within 5 days of any planned study procedure)
• Unstable angina
• Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
• Recurrent syncope
• Active endocarditis
• Acute myocarditis or pericarditis
• Symptomatic severe aortic stenosis
• Uncontrolled heart failure
• Acute (within 3 months) pulmonary embolus or pulmonary infarction
• Thrombosis of lower extremities
• Suspected dissecting aneurysm
• Uncontrolled asthma
• Pulmonary edema
• Room air desaturation at rest =< 85%
• Respiratory failure
• Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (ie infection, renal failure, thyrotoxicosis)
• Mental impairment leading to inability to cooperate NON-RANDOMIZED OBSERVATIONAL AND INTERVENTION COMPONENTS (ARM C): The same exclusion criteria apply as above. Additionally, • Should have no prior history of cancer, except for non-melanoma skin cancer

View trial on ClinicalTrials.gov